Poster
159
(#159) Long-Term Efficacy of Adjunctive Cariprazine Across Individual Depressive Symptoms in Adults With Major Depressive Disorder: Post Hoc Analysis of a 26-Week Open-Label Study
Psych Congress 2025
Abstract: Background: Cariprazine is a dopamine D3-preferring D3/D2 receptor and serotonin 5HT1A receptor partial agonist approved as an adjunctive treatment for adults with major depressive disorder (MDD). This post hoc analysis evaluated the durability of cariprazine's effects on individual depressive symptoms over time.
Methods: Adults with MDD and an inadequate response to antidepressant therapy (ADT) who either completed an 8-week lead-in study (NCT01715805) or were newly recruited into the open-label study received flexible-dose cariprazine (1.5-4.5 mg/day) plus ADT for 26 weeks (NCT01838876). Changes from baseline to week 26 in Montgomery Åsberg Depression Rating Scale (MADRS) item scores were summarized with descriptive statistics. Analyses included all patients who received ≥ 1 cariprazine dose and had baseline and ≥ 1 postbaseline efficacy assessments.
Results: There were 336 participants in the analysis. Improvements in the 10 MADRS item scores were observed as early as week 4 and sustained through week 26. Mean ± SD point improvements from baseline to week 26 for the MADRS items were: apparent sadness ‑1.45 ± 1.55, reported sadness ‑1.48 ± 1.60, inner tension ‑1.00 ± 1.42, reduced sleep ‑1.27 ± 1.68, reduced appetite ‑0.77 ± 1.32, concentration difficulty ‑1.29 ±1.51, lassitude ‑1.13 ± 1.60, inability to feel ‑1.38 ± 1.68, pessimistic thoughts ‑0.94 ± 1.46, and suicidal thoughts ‑0.19 ± 0.66.
Conclusion: Adjunctive cariprazine was associated with early and sustained improvements across MADRS items. Along with previous safety findings, the results suggest that adjunctive cariprazine is safe and well tolerated, with potentially durable effects on individual depressive symptoms.
Short Description: Cariprazine, when added to antidepressant therapy, can help adults with major depressive disorder (MDD) who have not had an adequate response to antidepressants alone. In a long-term, open-label safety study of adjunctive cariprazine, adults with MDD improved on all 10 items of a depressive symptoms scale, starting as early as week 4 and lasting through week 26. This adds to evidence suggesting adjunctive cariprazine may be effective for long-term treatment of specific core depressive symptoms.
Name of Sponsoring Organization(s): AbbVie Inc.
Methods: Adults with MDD and an inadequate response to antidepressant therapy (ADT) who either completed an 8-week lead-in study (NCT01715805) or were newly recruited into the open-label study received flexible-dose cariprazine (1.5-4.5 mg/day) plus ADT for 26 weeks (NCT01838876). Changes from baseline to week 26 in Montgomery Åsberg Depression Rating Scale (MADRS) item scores were summarized with descriptive statistics. Analyses included all patients who received ≥ 1 cariprazine dose and had baseline and ≥ 1 postbaseline efficacy assessments.
Results: There were 336 participants in the analysis. Improvements in the 10 MADRS item scores were observed as early as week 4 and sustained through week 26. Mean ± SD point improvements from baseline to week 26 for the MADRS items were: apparent sadness ‑1.45 ± 1.55, reported sadness ‑1.48 ± 1.60, inner tension ‑1.00 ± 1.42, reduced sleep ‑1.27 ± 1.68, reduced appetite ‑0.77 ± 1.32, concentration difficulty ‑1.29 ±1.51, lassitude ‑1.13 ± 1.60, inability to feel ‑1.38 ± 1.68, pessimistic thoughts ‑0.94 ± 1.46, and suicidal thoughts ‑0.19 ± 0.66.
Conclusion: Adjunctive cariprazine was associated with early and sustained improvements across MADRS items. Along with previous safety findings, the results suggest that adjunctive cariprazine is safe and well tolerated, with potentially durable effects on individual depressive symptoms.
Short Description: Cariprazine, when added to antidepressant therapy, can help adults with major depressive disorder (MDD) who have not had an adequate response to antidepressants alone. In a long-term, open-label safety study of adjunctive cariprazine, adults with MDD improved on all 10 items of a depressive symptoms scale, starting as early as week 4 and lasting through week 26. This adds to evidence suggesting adjunctive cariprazine may be effective for long-term treatment of specific core depressive symptoms.
Name of Sponsoring Organization(s): AbbVie Inc.
